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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501172-25-00 | Other Identifier | EU CT |
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A migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The main goal of the study is to evaluate the tolerability (how patients handle the study treatment) and safety of atogepant compared to topiramate in participants with migraine.
Atogepant is a medicine currently approved for the preventive treatment of adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied for the preventative treatment of migraine globally. Topiramate is an approved medication for migraine prevention. This study is conducted in 2 periods. In Period 1, participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate. In Period 2, eligible participants will receive atogepant. Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world.
Participants will receive atogepant (and placebo for topiramate) or topiramate (and placebo for atogepant) for 24 weeks in Period 1. Both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth. After 24 weeks, all eligible participants will receive atogepant for 52 weeks in Period 2. Participants are monitored for safety for 4 weeks after their last study treatment.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atogepant | Experimental | Participants will receive atogepant in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period. |
|
| Topiramate | Active Comparator | Participants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atogepant | Drug | Oral Tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Discontinued Treatment Due to Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Treatment-emergent adverse events (TEAEs) are defined as any AE with an onset date on or after the date of first dose of study drug during the Double Blind (DB) treatment period; and on or before the date of last dose of study drug during the DB treatment period (including tapering off phase, if applicable) + 30 days; and before the date of first dose of study drug during the Open Label (OL) treatment period, if applicable. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving ≥ 50% Improvement (Reduction) in Mean Monthly Migraine Days (MMD) During Months 4 to 6 (DB Period) | The mean monthly migraine days across Months 4 to 6 is calculated by taking the 3-month average of monthly migraine days over Months 4 to 6. The monthly migraine days is defined as the total number of recorded migraine days in the eDiary divided by the total number of days with eDiary records during each monthly period and multiplied by 28. The responder status of 50% reduction from Baseline is defined as a participant with at least a 50% reduction from Baseline in the 3-month average of monthly migraine days over Months 4 to 6. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universitaet Wien /ID# 247119 | Vienna | State of Vienna | 1090 | Austria | ||
| Medizinische Universitaet Innsbruck /ID# 247213 |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| ID | Title | Description |
|---|---|---|
| FG000 | DB: Topiramate | Double Blind Period (DB): Participants will receive topiramate oral capsule (up to highest dose tolerated: 50, 75, or 100 mg/day) either once daily (QD) or twice daily (BID) and placebo for atogepant oral tablet for 24 weeks. |
| FG001 | DB: Atogepant |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double Blind (DB) Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 17, 2024 | Apr 1, 2026 |
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| Placebo for Atogepant | Drug | Oral Tablet |
|
| Topiramate | Drug | Oral Capsule |
|
| Placebo for Topiramate | Drug | Oral Capsule |
|
| Months 4 to 6 (DB Period) |
| Change From Baseline in Mean Monthly Migraine Days During Months 4 to 6 (DB Period) | The mean monthly migraine days across Months 4 to 6 is calculated by taking the 3-month average of monthly migraine days over Months 4 to 6. The monthly migraine days is defined as the total number of recorded migraine days in the eDiary divided by the total number of days with eDiary records during each monthly period and multiplied by 28. | Baseline to Month 4 to Month 6 (DB Period) |
| Change From Baseline in the Total 6-Item Headache Impact Test (HIT-6) Score at Week 24 | The HIT-6 is a 6-item assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home and in social situations. It assesses the effect that headaches have on normal daily life and the subject's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses, each of which is assigned a score ranging from 6 points (never) to 13 points (always). Negative changes from Baseline in the HIT-6 score indicate improvement. | Baseline to Week 24 |
| Change From Baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score At Week 24 | MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: Role Function Restrictive, Role Function Preventive, and Emotional Function domain. Participants respond to items using a 6-point scale ranging from "none of the time" to "all of the time." Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. | Baseline to Week 24 |
| Percentage of Participants Achieving a Rating of "Much Better" or "Very Much Better" Assessed by the Patient Global Impression of Change (PGIC) | The Patient Global Impression of Change (PGIC) is a 7-point response scale. The participant response to the question, "Since you started the study treatment, how would you rate the change in your overall condition?" was assessed. Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome. | Week 24 |
| Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function - Abilities Subset - Short Form 6a Version 2.0 Score | The Patient Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function and Cognitive Function Abilities Subset item banks assess patient perceived cognitive deficits (i.e., mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes) over the past 7 days. A 5-level response scale for all 6 items ranges from 1 (Not at all) to 5 (Very much). The raw score of PROMIS-CF is the sum of all 6 items, ranging from 6 to 30. The raw score is standardized into a T-score with a mean of 50 and standard deviation of 10. Higher scores indicate a better cognitive function. | Baseline to Week 6 |
| Innsbruck |
| Tyrol |
| 6020 |
| Austria |
| Konventhospital Barmherzige Brueder Linz /ID# 247217 | Linz | Upper Austria | 4021 | Austria |
| Universitair Ziekenhuis Brussel /ID# 246959 | Jette | Brussels Capital | 1090 | Belgium |
| Jessa Ziekenhuis /ID# 246954 | Hasselt | Limburg | 3500 | Belgium |
| UZ Gent /ID# 246957 | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| AZ Sint-Jan Brugge /ID# 246962 | Bruges | 8000 | Belgium |
| CHR de la Citadelle /ID# 246964 | Liège | 4000 | Belgium |
| Vancouver Island Health Authority /ID# 247733 | Victoria | British Columbia | V8R 1J8 | Canada |
| Maritime Neurology /ID# 247728 | Halifax | Nova Scotia | B3R 1V9 | Canada |
| Aggarwal and Associates Limited /ID# 247727 | Brampton | Ontario | L6T 0G1 | Canada |
| CCR Ostrava, s.r.o. /ID# 245924 | Ostrava | Ostrava-mesto | 702 00 | Czechia |
| A-Shine s.r.o. /ID# 245923 | Pilsen | Plzeň Region | 301 00 | Czechia |
| Praglandia /ID# 247511 | Prague | Praha 5 | 150 00 | Czechia |
| NeuroHK s.r.o. /ID# 247500 | Hradec Králové | 500 09 | Czechia |
| Pratia Pardubice a.s. /ID# 249017 | Pardubice | 530 02 | Czechia |
| Clintrial s.r.o. /ID# 245926 | Prague | 100 00 | Czechia |
| Pratia Prague s.r.o. /ID# 245925 | Prague | 130 00 | Czechia |
| Fakultni Thomayerova nemocnice /ID# 249016 | Prague | 140 59 | Czechia |
| INEP medical s.r.o. /ID# 245927 | Prague | 186 00 | Czechia |
| Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 247562 | Bron | Rhone | 69500 | France |
| CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 247561 | Clermont-Ferrand | 63000 | France |
| AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 249244 | Paris | 75010 | France |
| Studienzentrum fuer Neurologie und Psychiatrie /ID# 249236 | Böblingen | Baden-Wurttemberg | 71034 | Germany |
| Universitaetsklinikum Tuebingen /ID# 246043 | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Neuropoint GmbH /ID# 246038 | Ulm | Baden-Wurttemberg | 89073 | Germany |
| Neuropraxis Muenchen Sued /ID# 246045 | Unterhaching | Bavaria | 82008 | Germany |
| Gesundheitszentrum Hoppegarten /ID# 249242 | Hoppegarten | Brandenburg | 15366 | Germany |
| Praxis fuer Neurologie, Psychiatrie und Psychotherapie /ID# 248427 | Bad Homburg | Hesse | 61348 | Germany |
| Kopfschmerzzentrum - Frankfurt /ID# 248686 | Frankfurt am Main | Hesse | 65929 | Germany |
| Klinische Forschung Hannover-Mitte GmbH /ID# 248565 | Hanover | Lower Saxony | 30159 | Germany |
| Studienzentrum Nord-West /ID# 246039 | Westerstede | Lower Saxony | 26655 | Germany |
| Klinische Forschung Schwerin GmbH /ID# 248074 | Schwerin | Mecklenburg-Vorpommern | 19055 | Germany |
| ZNS Siegen /ID# 251180 | Siegen | North Rhine-Westphalia | 57076 | Germany |
| Krankenhaus der Barmherzigen Brüder Trier /ID# 248564 | Trier | Rhineland-Palatinate | 54292 | Germany |
| Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 246030 | Chemnitz | Saxony | 09111 | Germany |
| Universitaetsklinikum Carl Gustav Carus Dresden /ID# 246040 | Dresden | Saxony | 01307 | Germany |
| Ambenet Hausarztpraxis /ID# 246028 | Leipzig | Saxony | 04107 | Germany |
| Schmerzklinik Kiel /ID# 246037 | Kiel | Schleswig-Holstein | 24149 | Germany |
| Neurologisches Facharztzentrum Berlin /ID# 248064 | Berlin | 10713 | Germany |
| Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 246029 | Berlin | 13353 | Germany |
| NeuroZentrum Bielefeld /ID# 250758 | Bielefeld | 33647 | Germany |
| Neuro Centrum Odenwald /ID# 248067 | Erbach im Odenwald | 64711 | Germany |
| Universitaetsklinikum Essen /ID# 246033 | Essen | 45147 | Germany |
| Universitaetsmedizin Greifswald /ID# 248574 | Greifswald | 17475 | Germany |
| Klinische Forschung Hamburg GmbH /ID# 248620 | Hamburg | 20253 | Germany |
| Neurologische Gemeinschaftspraxis Kassel und Vellmar /ID# 248085 | Kassel | 34121 | Germany |
| Lewis Neurologie /ID# 250498 | Stuttgart | 70178 | Germany |
| MIND Clinic /ID# 247867 | Budapest | 1024 | Hungary |
| Clinexpert Kft /ID# 247868 | Budapest | 1033 | Hungary |
| Semmelweis Egyetem /ID# 248428 | Budapest | 1085 | Hungary |
| S-Medicon Kft /ID# 247682 | Budapest | 1138 | Hungary |
| Debreceni Egeszsegugyi Kozpontja /ID# 247549 | Debrecen | 4025 | Hungary |
| Meir Medical Center /ID# 247261 | Kfar Saba | Central District | 4428164 | Israel |
| Hillel Yaffe Medical Center /ID# 247258 | Hadera | H_efa | 38100 | Israel |
| Shaare Zedek Medical Center /ID# 247259 | Jerusalem | Jerusalem | 91031 | Israel |
| Soroka University Medical Center /ID# 247260 | Beersheba | Southern District | 8410101 | Israel |
| Azienda Ospedaliero Universitaria Careggi /ID# 247575 | Florence | Firenze | 50134 | Italy |
| Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 247576 | Naples | Napoli | 80138 | Italy |
| IRCCS San Raffaele /ID# 247573 | Rome | Roma | 00163 | Italy |
| Azienda Ospedaliero-Universitaria di Modena /ID# 247578 | Modena | 41124 | Italy |
| Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 247579 | Pavia | 27100 | Italy |
| Fondazione Policlinico Universitario Campus Bio-Medico /ID# 247580 | Roma | 00128 | Italy |
| Solumed Centrum Medyczne /ID# 247317 | Poznan | Greater Poland Voivodeship | 60-529 | Poland |
| Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 247323 | Poznan | Greater Poland Voivodeship | 61-731 | Poland |
| Vitamed Galaj i Cichomski Sp.j. /ID# 247314 | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-079 | Poland |
| Athleticomed Sp. z o.o /ID# 250790 | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-752 | Poland |
| Instytut Zdrowia Dr Boczarska Jedynak /ID# 247315 | Oświęcim | Lesser Poland Voivodeship | 32-600 | Poland |
| Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247298 | Lublin | Lublin Voivodeship | 20-582 | Poland |
| RCMed Oddzial Sochaczew /ID# 247378 | Sochaczew | Masovian Voivodeship | 96-500 | Poland |
| ETG Neuroscience Sp. z o.o. /ID# 247331 | Warsaw | Masovian Voivodeship | 02-677 | Poland |
| Silmedic Sp. z o.o. /ID# 247376 | Katowice | Silesian Voivodeship | 40-282 | Poland |
| Hospital Garcia de Orta /ID# 247163 | Almada | Setúbal District | 2805-267 | Portugal |
| 2CA-Braga, Hospital de Braga /ID# 247165 | Braga | 4710-243 | Portugal |
| Hospital da Luz Lisboa /ID# 247168 | Lisbon | 1500-650 | Portugal |
| Unidade Local de Saude de Santa Maria, EPE /ID# 247167 | Lisbon | 1649-035 | Portugal |
| Hospital Prof. Doutor Fernando Fonseca, EPE /ID# 247172 | Lisbon | 2720-276 | Portugal |
| Unidade Local de Saúde de Matosinhos, EPE /ID# 247169 | Matosinhos Municipality | 4464-513 | Portugal |
| The Adam Practice /ID# 248880 | Poole | Dorset | BH15 4JQ | United Kingdom |
| Duplicate_NHS Greater Glasgow and Clyde /ID# 247979 | Glasgow | Scotland | G12 0XH | United Kingdom |
| West Walk Surgery /ID# 252855 | Bristol | BS37 4AX | United Kingdom |
Double Blind Period (DB): Participants will receive atogepant 60 mg oral tablets once daily (QD) and placebo for topiramate for 24 weeks. |
| FG002 | OL: Atogepant | Open Label (OL) Period: Starting at week 25, eligible participants from either arm the DB period will receive atogepant 60 mg oral tablets QD for 52 weeks. |
| Treated |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| Open Label (OL) Period |
|
|
ITT - Intent-to-Treat Population includes all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Topiramate | Double Blind Period (DB): Participants will receive topiramate oral capsule (up to highest dose tolerated: 50, 75, or 100 mg/day) either once daily (QD) or twice daily (BID) and placebo for atogepant oral tablet for 24 weeks. |
| BG001 | Atogepant | Double Blind Period (DB): Participants will receive atogepant 60 mg oral tablets once daily (QD) and placebo for topiramate for 24 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Who Discontinued Treatment Due to Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Treatment-emergent adverse events (TEAEs) are defined as any AE with an onset date on or after the date of first dose of study drug during the Double Blind (DB) treatment period; and on or before the date of last dose of study drug during the DB treatment period (including tapering off phase, if applicable) + 30 days; and before the date of first dose of study drug during the Open Label (OL) treatment period, if applicable. | Safety Population 1 - All participants who received at least 1 dose of study treatment during the DB treatment period. Here, 'Overall Number of Participants Analyzed' is the number of participants evaluable for this Endpoint. | Posted | Number | percentage of participants | Week 24 |
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| Secondary | Percentage of Participants Achieving ≥ 50% Improvement (Reduction) in Mean Monthly Migraine Days (MMD) During Months 4 to 6 (DB Period) | The mean monthly migraine days across Months 4 to 6 is calculated by taking the 3-month average of monthly migraine days over Months 4 to 6. The monthly migraine days is defined as the total number of recorded migraine days in the eDiary divided by the total number of days with eDiary records during each monthly period and multiplied by 28. The responder status of 50% reduction from Baseline is defined as a participant with at least a 50% reduction from Baseline in the 3-month average of monthly migraine days over Months 4 to 6. | Modified Intent-to-Treat (mITT) Population - all randomized participants who received at least 1 dose of study drug, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week (1 month) period of eDiary data within 24 weeks after the first dose of study drug (Month 1 to Month 6), regardless of whether on study drug or off study drug. | Posted | Number | percentage of participants | Months 4 to 6 (DB Period) |
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| Secondary | Change From Baseline in Mean Monthly Migraine Days During Months 4 to 6 (DB Period) | The mean monthly migraine days across Months 4 to 6 is calculated by taking the 3-month average of monthly migraine days over Months 4 to 6. The monthly migraine days is defined as the total number of recorded migraine days in the eDiary divided by the total number of days with eDiary records during each monthly period and multiplied by 28. | Modified Intent-to-Treat (mITT) Population - all randomized participants who received at least 1 dose of study drug, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week (1 month) period of eDiary data within 24 weeks after the first dose of study drug (Month 1 to Month 6), regardless of whether on study drug or off study drug. Here, 'Overall Number of Participants Analyzed' is the number of participants evaluable for this Endpoint. | Posted | Least Squares Mean | Standard Error | mean monthly migraine days | Baseline to Month 4 to Month 6 (DB Period) |
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| Secondary | Change From Baseline in the Total 6-Item Headache Impact Test (HIT-6) Score at Week 24 | The HIT-6 is a 6-item assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home and in social situations. It assesses the effect that headaches have on normal daily life and the subject's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses, each of which is assigned a score ranging from 6 points (never) to 13 points (always). Negative changes from Baseline in the HIT-6 score indicate improvement. | Modified Intent-to-Treat (mITT) Population - all randomized participants who received at least 1 dose of study drug, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week (1 month) period of eDiary data within 24 weeks after the first dose of study drug (Month 1 to Month 6), regardless of whether on study drug or off study drug. Here, 'Overall Number of Participants Analyzed' is the number of participants evaluable for this Endpoint. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Week 24 |
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| Secondary | Change From Baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score At Week 24 | MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: Role Function Restrictive, Role Function Preventive, and Emotional Function domain. Participants respond to items using a 6-point scale ranging from "none of the time" to "all of the time." Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. | Modified Intent-to-Treat (mITT) Population - all randomized participants who received at least 1 dose of study drug, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week (1 month) period of eDiary data within 24 weeks after the first dose of study drug (Month 1 to Month 6), regardless of whether on study drug or off study drug. Here, 'Overall Number of Participants Analyzed' is the number of participants evaluable for this Endpoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 24 |
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| Secondary | Percentage of Participants Achieving a Rating of "Much Better" or "Very Much Better" Assessed by the Patient Global Impression of Change (PGIC) | The Patient Global Impression of Change (PGIC) is a 7-point response scale. The participant response to the question, "Since you started the study treatment, how would you rate the change in your overall condition?" was assessed. Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome. | Modified Intent-to-Treat (mITT) Population - all randomized participants who received at least 1 dose of study drug, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week (1 month) period of eDiary data within 24 weeks after the first dose of study drug (Month 1 to Month 6), regardless of whether on study drug or off study drug. | Posted | Number | percentage of participants | Week 24 |
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| Secondary | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function - Abilities Subset - Short Form 6a Version 2.0 Score | The Patient Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function and Cognitive Function Abilities Subset item banks assess patient perceived cognitive deficits (i.e., mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes) over the past 7 days. A 5-level response scale for all 6 items ranges from 1 (Not at all) to 5 (Very much). The raw score of PROMIS-CF is the sum of all 6 items, ranging from 6 to 30. The raw score is standardized into a T-score with a mean of 50 and standard deviation of 10. Higher scores indicate a better cognitive function. | Modified Intent-to-Treat (mITT) Population - all randomized participants who received at least 1 dose of study drug, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week (1 month) period of eDiary data within 24 weeks after the first dose of study drug (Month 1 to Month 6), regardless of whether on study drug or off study drug. Here, 'Overall Number of Participants Analyzed' is the number of participants evaluable for this Endpoint. | Posted | Least Squares Mean | Standard Error | T-score | Baseline to Week 6 |
|
All-cause mortality and adverse event tables include events reported from the time of informed consent until time of interim analysis. The median time on follow-up (or mean time participants were followed) was 168.0, 168.0, and 166.0 days for arms DB: Atogepant, DB: Topiramate, and OL: Atogepant, respectively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DB: Topiramate | Double Blind Period (DB): Participants will receive topiramate oral capsule (up to highest dose tolerated: 50, 75, or 100 mg/day) either once daily (QD) or twice daily (BID) and placebo for atogepant oral tablet for 24 weeks. | 0 | 272 | 3 | 272 | 189 | 272 |
| EG001 | DB: Atogepant | Double Blind Period (DB): Participants will receive atogepant 60 mg oral tablets once daily (QD) and placebo for topiramate for 24 weeks. | 0 | 273 | 7 | 273 | 154 | 273 |
| EG002 | OL: Atogepant | Open Label (OL) Period: Starting at week 25, eligible participants from either arm the DB period will receive atogepant 60 mg oral tablets QD for 52 weeks. | 0 | 457 | 8 | 457 | 61 | 457 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BRADYCARDIA | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| INFLAMMATION | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| CARTILAGE INJURY | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| EPICONDYLITIS | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| ULNA FRACTURE | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| GLIOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| MIGRAINE | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| THUNDERCLAP HEADACHE | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| MIXED ANXIETY AND DEPRESSIVE DISORDER | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
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| RENAL FAILURE | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| UTEROVAGINAL PROLAPSE | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 23, 2025 | Apr 1, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718987 | atogepant |
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D007661 | Ketoses |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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|
Double Blind Period (DB): Participants will receive atogepant 60 mg oral tablets once daily (QD) and placebo for topiramate for 24 weeks. |
|
|
|
Double Blind Period (DB): Participants will receive atogepant 60 mg oral tablets once daily (QD) and placebo for topiramate for 24 weeks. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Atogepant |
Double Blind Period (DB): Participants will receive atogepant 60 mg oral tablets once daily (QD) and placebo for topiramate for 24 weeks. |
|
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|